Država: Izrael
Jezik: angleščina
Source: Ministry of Health
RIVAROXABAN
BAYER ISRAEL LTD
B01AX06
FILM COATED TABLETS
RIVAROXABAN 10 MG
PER OS
Required
BAYER HEALTHCARE MANUFACTURING S.R.L, ITALY
RIVAROXABAN
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.Prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE), adults (following completion of at least 6 months therapy for DVT or PE).
2018-01-04
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only Each tablet contains: Rivaroxaban 10 mg Inactive ingredients and allergens in the preparation: See section 6 “Further Information” and in section 2 “Important information regarding some of the ingredients of the medicine”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. In addition to the leaflet, the Xarelto 10 mg preparation is provided with a Patient Safety Information Card. This card contains important information that you must know and abide by before starting and during treatment with Xarelto 10 mg. Read the Patient Safety Information Card and the patient leaflet before starting to use the preparation. Keep the card and leaflet for further reading if necessary. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1) WHAT IS THE MEDICINE INTENDED FOR? Xarelto 10 mg is intended for: - preventing venous thrombosis in adults following elective hip or knee replacement surgery. - preventing recurrence of venous thrombosis in the legs (deep-vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) after completion of 6 months of treatment for a previous deep-vein thrombosis or pulmonary embolism. THERAPEUTIC GROUP: Xarelto 10 mg belongs to a group of medicines called antithrombotic agents and acts by lowering the tendency to form blood clots by blocking a factor involved in the blood-clotting process (Factor 10a). 2) BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are sensitive (allergic) to rivaroxaban or to any of the other ingredients contained in the medicine. For the list of inactive ingredients, see section 6 “Further Information”. • you are su Preberite celoten dokument
1 1. NAME OF THE MEDICINAL PRODUCT Xarelto 10 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg rivaroxaban. Excipient with known effect: Each film-coated tablet contains 27.9 mg lactose monohydrate, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Light red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "10" and a triangle on the other side._ _ Prescriber guide This product is marketed with prescriber guide providing recommendations for the risk minimization in the use of Xarelto 10mg. Please ensure you are familiar with this material as it contains important safety information. Patient safety information card The marketing of Xarelto 10 mg is subject to a risk management plan (RMP) including a 'patient safety information card' (Patient card). Please provide a patient card to each patient who is prescribed with Xarelto 10 mg. The 'patient safety information card', emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment and the implications of this treatment including the need for compliance. Please also explain the signs of important adverse events and instruct the patient when to seek medical care. WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. If anticoagulation with XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant _[see posology _ _and method of administration (4.2), and special warnings and precautions for _ _use (4.4)]_. B. SPINAL/EPIDURAL HEMATOMA Preberite celoten dokument